Package leaflet: Information for the patient

Finamef, 5 mg, film-coated tablets
finasteride
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others.
This medicine may harm others, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

What Finamef is and what it is used for
Important information before taking Finamef
How to take Finamef
Possible side effects
How to store Finamef
Contents of the pack and other information

1. What Finamef is and what it is used for

The active substance in Finamef is finasteride, which belongs to a group of medicines known as 5-alpha-reductase inhibitors. It works by reducing the size of the prostate gland in men.
Finamef is used in the treatment and management of enlarged prostate (benign prostatic hyperplasia, BPH). It reduces the size of the enlarged prostate, improves urine flow, relieves BPH-related symptoms, and reduces the risk of acute urinary retention and the need for surgical intervention.

2. Important information before taking Finamef

When not to take Finamef:

if the patient is allergic to finasteride or any of the other ingredients of Finamef (listed in section 6);
if the patient is pregnant or may be pregnant, use of Finamef in women is contraindicated. Particular caution is advised for women who are or may be pregnant and may come into contact with Finamef (see section "Pregnancy, breastfeeding and effect on fertility").

Finamef is not recommended for use in children.
IF IN DOUBT, ALWAYS CONSULT A DOCTOR OR
PHARMACIST.
Warnings and precautions
Before starting Finamef, discuss this with your doctor or pharmacist.

if the patient has a large residual urine volume and/or significantly reduced urinary flow. In such cases, the patient should be carefully monitored for urinary tract obstruction;
if the patient has impaired liver function. In these patients, serum concentrations of finasteride may be increased;
if the patient's sexual partner is pregnant or may be pregnant, exposure to semen, which may contain small amounts of the drug, should be avoided.

Breast cancer
Inform your doctor immediately if any changes in breast tissue occur, such as lumps, pain or nipple discharge, as these may be symptoms of a serious condition such as breast cancer.
Effect on Prostate-Specific Antigen (PSA)
Before starting Finamef and during treatment, the patient should undergo physical examination (including digital rectal examination) and serum prostate-specific antigen (PSA) testing.
This medicine lowers serum PSA levels, which should be taken into account in differential diagnosis.
Mood changes and depression
Mood changes such as depressive mood and depression, and less frequently suicidal thoughts, have been reported in patients taking Finamef. If any of these symptoms occur, seek immediate medical advice from your doctor.
Finamef and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
No clinically significant interactions have been reported.
Pregnancy, breastfeeding and effect on fertility
Finamef is intended for use in men only.
Women who are pregnant or may be pregnant must not handle crushed or broken Finamef tablets.
If a pregnant woman carrying a male fetus absorbs finasteride through the skin or takes finasteride orally, there is a risk that the baby will be born with malformed genital organs. Finamef tablets are film-coated, which prevents contact with the active substance unless the tablet is broken or crushed.
If the patient's sexual partner is or may be pregnant, exposure to semen (e.g. by using a condom) should be avoided or the patient should discontinue finasteride.
It is not known whether this medicine passes into human breast milk.
Driving and operating machinery
There are no data indicating any effect of Finamef on the ability to drive or operate machinery.
Finamef contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Finamef

This medicine should always be taken as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 tablet per day (corresponding to a dose of 5 mg of finasteride).
The coated tablets can be taken with or without food. The tablets should be swallowed whole and must not be divided or crushed.
Despite the possibility of rapid clinical improvement, treatment should be continued for at least 6 months in order to properly assess its effectiveness.
Your doctor will advise you on how long to continue taking Finamef. Do not stop treatment prematurely on your own, as symptoms of the disease may return.

Liver function disorders
There is no experience with the use of Finamef in patients with liver function disorders (see also section "Warnings and precautions").

Renal function disorders
Dosage adjustment is not necessary.
Studies on Finamef in patients undergoing hemodialysis have not been conducted so far.

Elderly patients
Dosage adjustment is not necessary.
If you feel that the effect of Finamef is too strong or too weak, consult your doctor or pharmacist.

Overdose of Finamef
If you take more than the recommended dose of Finamef, or if you suspect that a child has accidentally swallowed the medicine, contact your doctor immediately.

Missed dose of Finamef
If you miss a dose of Finamef, take the missed dose as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and take the next dose at the regular scheduled time. Do not take a double dose to make up for the missed dose.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Allergic reactions
If an allergic reaction occurs, stop taking the medicine immediately and contact your doctor as soon as possible. Symptoms may include:

swelling of the lips, face, tongue, and throat
difficulty swallowing
skin rash, itching, subcutaneous lumps (urticaria)
difficulty breathing

Other adverse effects:
Common (may affect up to 1 in 10 people):

difficulty achieving an erection (impotence)
reduced sexual desire
reduced volume of semen during ejaculation. Reduced semen volume does not appear to affect normal sexual function. The adverse effects listed above may resolve over time in patients continuing treatment with Finamef. If symptoms persist during treatment, they usually resolve after stopping Finamef.

Uncommon (may affect up to 1 in 100 people):

rash
swelling or tenderness of the breasts
problems with ejaculation, which may persist after discontinuation of the medicine

Unknown frequency (cannot be estimated from available data):

anxiety
suicidal thoughts
palpitations (awareness of heartbeat)
changes in liver function, which may be evident in blood tests
testicular pain
male infertility and (or) poor semen quality. Improvement in semen quality has been observed after discontinuation of treatment
depression
reduced sexual desire, which may persist after discontinuation of treatment
erectile and ejaculation disorders, which may persist after discontinuation of treatment
blood in semen

Seek immediate medical advice if you notice any changes in breast tissue, such as lumps, pain, breast enlargement, or nipple discharge, as these may be signs of a serious condition, such as breast cancer.
Finasteride may affect the results of prostate-specific antigen (PSA) testing.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Finamef

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister pack, and bottle
following the abbreviation "EXP". The expiry date refers to the last day of the specified month.
The batch number on the packaging follows the abbreviation "Lot".
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Proper disposal helps
protect the environment.

6 Contents of the packaging and other information

What Finamef contains

The active substance is finasteride. Each coated tablet contains 5 mg of finasteride.
Other ingredients include: monohydrate lactose, microcrystalline cellulose, sodium carboxymethyl starch (type A), pregelatinized starch (corn), povidone K30, magnesium stearate, sodium lauryl sulfate, hypromellose 6cP, titanium dioxide (E171), macrogol 6000, macrogol 400, indigo carmine (E132).

What Finamef looks like and contents of the pack

Finamef coated tablets are blue, capsule-shaped, with the imprint "FNT5" on one side.

Finamef is available in blister packs containing 28, 30, 60, 90, or 105 tablets, and in HDPE bottles with polypropylene caps containing 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel. (22) 345 93 00
Poland

Manufacturers:
Pharmachemie B.V.
Swensweg 5, Postbus 552
2003 RN Haarlem
The Netherlands

TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 Debrecen
Hungary

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
Poland

This medicinal product is authorised for sale in the Member States of the European Economic Area under the following names:

Belgium: Finasteride Teva 5 mg filmomhulde tabletten
Denmark: Finasteride Teva 5 mg
Estonia: Finasteride Teva
France: Finasteride Teva 5 mg, comprimé pelliculé
Hungary: Finasterid-TEVA 5 mg filmtabletta
Italy: FINASTERIDE Teva Italia 5 mg compresse rivestite con film
Latvia: Finasteride Teva 5 mg apvalkotās tabletes
Lithuania: Finasteride Teva 5 mg plėvele dengtos tabletės
Netherlands: Finasteride 5 mg Teva
Poland: Finamef
Portugal: Finasterida-Teva
Spain: Finasterida Teva-ratiopharm 5 mg comprimidos recubiertos con película EFG
Sweden: Finasteride Teva 5 mg filmdragerad tablett